We attended PHSS CMC&GMP Course in 2026
The course was organised by PHSS with title 'Chemistry, Manufacturing and Controls (CMC) & GMP, with a specific focus on Biologics & Advanced Therapy Medicinal Products (ATMPs) and took place in London during the 24th and 25th of February 2026. Some of the topics included...:
- CMC which applies through drug develop GMP applies), and at scale up, where comparability applies through Commercial GMP manufacturing.
- Control strategies are required for Product manufacturing, Contamination Control and Cross Contamination control with CMC and GMP remaining connected through such strategies.
- The need to understand EU and US expectations for regulatory CMC for biologics and ATMPs both during Clinical Development
and at Licensure.
...and much more!.
We attended PHSS QRM Seminar in 2026
On the 10th February, Lara attended the PHSS Seminar in Bristol, on Quality Risk Management (QRM) and Process Risk Management (PRM) for Annex 1 Compliance. It was a really insightful day, with discussions on regulatory expectations and the key updates in ICH Q9 (R1) — including hazard identification, managing product availability and supply risks, reducing subjectivity, understanding the appropriate level of formality in QRM, risk‑based decision making, and effective risk reviews.
The Seminar also covered practical case studies on applying QRM to ATMPs, risk‑based contamination control models and how to build strong, compliant Contamination Control Strategies.
We attended EPiC Auditors Virtual Symposium in November 2025
In November 2024, Lara Gonzalez-Ruiz, Executive Director of LGZ Quality Services Ltd, attended the EPiC GMDP Virtual Symposium. The Symposium delivered a review of key GMDP topics as well as shared insights from a team of professionals with lots of knowledge and years of experience.
Sterile Product Manufacturing Conference in 2025
The PHSS conference took place in Macclesfied, starting with a tour of AstraZeneca, followed by a day full of sessions addressing the key challenges in sterile product manufacture including regulatory updates, processing of intermediates that require low bioburden control. decentralised manufacturing, sterility assurance and much more!
LGZ's Customer Feedback, January 2025
At LGZ Quality Services Ltd we have conducted an annual review of our customers’ feedback and we are delighted to share some of the feedback with you:
👍 “ Thank you for the quick action. Also, thank you again for your help during
the site visit. It was a pleasure to meet you and hopefully we will work
together again”.
👍 “Thanks again, for your feedback so far, your insight is very useful in
helping us improve our quality systems here”.
👍 “Thank you for having recommended LGZ Quality Services Ltd to support
us”.
👍 “Very efficient auditor and good communication style”.
👍 “A very comprehensive report, I really enjoyed reading it!”.
👍 “Excellent! Congratulations. Very good report! Very complete and well
described”.
If you would like to contribute in our next annual review, contact us to see what we can do for you!
We attended EPiC Auditors Virtual Symposium in November 2024
In November 2024, Lara Gonzalez-Ruiz, Executive Director of LGZ Quality Services Ltd, attended the EPiC GMDP Virtual Symposium. The Symposium delivered a review of key GMDP topics as well as shared insights from a team of professionals with lots of knowledge and years of experience.
Preparing for a Client’s Supplier Audit
Click on link below to read this 3 minute article about the key points to consider when preparing for an audit:
Preparing for a Client’s Supplier Audit | LinkedIn
Mock PAIs Italy & Switzerland, April 2024
Travelling back from Geneva, after conducting two Mock PAI Audit on behalf of a Client.
At LGZ Quality Services Ltd , we can support your business in conducting Mock PAI audits and Gap Assessments.
PHSS Sterile Product Manufacturing Conference, March 2024
In March 2024, Lara Gonzalez-Ruiz, Executive Director of LGZ Quality Services Ltd, attended the 1.5-day Sterile Product Manufacturing and Aseptic Conference, organised by PHSS, the Pharmaceutical & Healthcare Sciences Society.
The conference was packed with really interesting talks by subject matter experts within the Pharma and Biopharma industry, presenting the following topics:
- Challenges to particulate counter installation and qualification to manage particle loss in sampling and strategies to address them, by Julian Kay from GSK
- Implementation of a new isolator-based filling line for sterile fill-finish of vial vectors, by Leslie Southam from Oxford Biomedica
- Practical validation/application of Enzyme Indicators in vH202 surface decontamination, by Birte Scharf from Franz Ziel GmbH
- Forming confident connections in fluid pathway, by Katie Church from Watson Marlow
- Regulatory Insights discussions, by Malcolm Holmes from PHSS
- Panel’s perspective, including MHRA and leading SMEs to answer any questions
- MHRA views on GMP impact and assessment processes, by Martine Powell, MHRA Expert GMP Inspector
- Risk management of contaminants in gowning in future sites, by Matts Ramstrop from BioTekPro
- Flexible manufacturing – facilities for multiple processes and scales, by Andrew Besso from eXmoor Pharma
- Annex I and ISO TR14644-21, by Gordon Farquharson from Critical Systems Ltd
- Challenges with transferring to ATMP, by Tamryn Hassel
- Rapid methods vs. conventional implementation, by Tim Sandle, BPL
- VR presentation and demonstration, by Stephen Steward from Catapult GCT
- Annex I updates – QRM principles and risk based holistic implementation, by Di Morris, PHSS/PNR/Pharma (ex-MHRA)
Travelling to Europe...
October 2023...busy Monday morning traveling to EU to conduct a 2-day routine GMP audit. LGZ Quality Services Ltd can support your business in conducting approval, routine, for-cause audits and mock inspections news & articles
GMDP Compliance and Inspection Readiness
December 2023...
Thank you to EPiC Auditors. A well organised Symposium, packed with very informative and relevant GMDP topics for compliance and inspection readiness, presented by knowledgeable and experienced speakers.
PHSS Annual Conference 2023
September 2023...Thank you everybody at PHSS for organising such a good conference, full of interesting speakers and panel discussions! news & articles